Alcohol Use and Mental Health - Pilot Test of Video-assisted Drinking Topography

NCT03314454 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB201700455
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal is to pilot test and establish a procedure for video-assisted alcohol topography and explore its utility as an indicator of alcohol use disorder. There are 4 phases to this study: 1) pre-screening by phone; 2) in-person screening appointment; 3) the first alcohol drinking session with videotaping; and 4) follow-up appointment for retest.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (4)

• Alcohol Topography: Sip Frequency

  To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean number of sips per alcoholic drink

  60 days (from phone screening to follow-up retest)

• Alcohol Topography: Sip Interval

  To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean interval between sips

  60 days (from phone screening to follow-up retest)

• Alcohol Topography: Sip Duration

  To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean sip duration

  60 days (from phone screening to follow-up retest)

• Alcohol Topography: Sip Amount.

  To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in multiple ways including the current measure: mean amount of beer consumed per sip

  60 days (from phone screening to follow-up retest)

Study Arms (4)

Elevated Mental Status

ACTIVE COMPARATOR

Elevated score on Patient Health Questionnaire

Drug: Beer; Device: Videotaped drinking session

Non-elevated depressed mood

ACTIVE COMPARATOR

Lower score on Patient Health Questionnaire

Drug: Beer; Device: Videotaped drinking session

Social Drinking status

ACTIVE COMPARATOR

The social drinker group will be those who consume alcohol regularly but with infrequent heavy drinking days.

Drug: Beer; Device: Videotaped drinking session

Heavy drinker status

ACTIVE COMPARATOR

The heavy drinker group will be those who consume alcohol regularly with frequent heavy drinking days.

Drug: Beer; Device: Videotaped drinking session

Interventions

Beer DRUG

Common brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV)

Elevated Mental Status; Heavy drinker status; Non-elevated depressed mood; Social Drinking status

Videotaped drinking session DEVICE

Video-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder

Also known as: video-assisted topography

Elevated Mental Status; Heavy drinker status; Non-elevated depressed mood; Social Drinking status

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be able to read/write English and complete study assessments
• Drink alcohol
• Healthy adults reporting alcohol consumption in the past 30 days
• Not currently seeking treatment for substance use
• Willingness to provide urine drug screening

You may not qualify if:

• Test positive on a urine test for use of certain illegal drugs
• Undergraduate student enrolled at the University of Florida
• Graduate students from the College of Health and Human Performance at the University of Florida
• Pregnant, or currently breast feeding

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

EDGE Laboratory

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Beer

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcoholic Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Beverages; Fermented Foods; Food and Beverages

Results Point of Contact

• Title: Dr. Robert Leeman
• Organization: Northeastern University

r.leeman@northeastern.edu

6173736501

Study Officials

• Robert Leeman, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are aware of the interventions, but are not aware of the assigned arm.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 19, 2017
• Study Start: October 12, 2017
• Primary Completion: December 15, 2022
• Study Completion: June 1, 2023
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2024-12

Locations

US (1)